The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients.

Device Description

The Langston dual lumen catheter consists of a coaxial tube (outer lumen) mounted over a braided catheter shaft (inner lumen) and an extension line with a 3-way stopcock. The extension line with stopcock connects to the outer lumen. The outer lumen, and extension line are joined by an over molded manifold. The manifold also includes a luer that connects to the inner lumen. The manifold is printed with the Langston catheter length, French size, maximum guidewire diameter, and product logo ("Langston"). The Langston dual lumen catheter tip terminates in either a pigtail or multipurpose tip configuration.

AI/ML Overview

The provided text describes a medical device, the Langston Dual Lumen Catheter, and its substantial equivalence to predicate devices, but it does not contain details about acceptance criteria or a study designed to prove the device meets specific performance criteria in the context of an AI/ML model for diagnosis or prediction.

The document is a 510(k) summary for a medical device (a catheter) seeking FDA clearance, demonstrating substantial equivalence to already cleared predicate devices. The "studies" mentioned are bench tests and biocompatibility tests to show that the new device's modifications (e.g., in manufacturing, materials) do not negatively impact its safety and performance compared to the previously cleared versions. These are not clinical studies in the sense of evaluating diagnostic accuracy or predictive performance through human reader evaluations or ground truth comparisons.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML model's performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for training sets, because this information is not present in the provided text.

The closest relevant information from the document is related to the performance verification of the physical medical device, not an AI component.

Here's a breakdown of what is available in the document, framed in the context of device performance, but noting its irrelevance to AI/ML model evaluation:

1. A table of acceptance criteria and the reported device performance:

The document broadly states: "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." It does not provide a table with specific quantitative acceptance criteria or detailed reported performance figures for each test. Instead, it lists the types of tests performed.

Acceptance Criteria Category (Implied)	Reported Device Performance
Package Integrity	Passed verification tests
Tortuosity in Simulated Anatomy	Passed verification tests
Pressure Monitoring	Passed verification tests
Flow Rate vs. Injection Pressure	Passed verification tests
Tensile Force	Passed verification tests
Torque to Failure	Passed verification tests
Air Leakage During Aspiration	Passed verification tests
Liquid Leakage Under Pressure	Passed verification tests
Torque Strength	Passed verification tests
Dimensional Analysis	Passed verification tests
Hub Luer Taper	Passed verification tests
Cytotoxicity	Passed biocompatibility tests
Sensitization	Passed biocompatibility tests
Irritation	Passed biocompatibility tests
Acute Systemic Toxicity	Passed biocompatibility tests
Pyrogenicity	Passed biocompatibility tests
Hemocompatibility	Passed biocompatibility tests

The following points are explicitly NOT present in the provided text, as they relate to AI/ML model evaluation, which is not the subject of this 510(k) summary:

Sample size used for the test set and the data provenance: Not applicable, no AI/ML test set mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no AI/ML ground truth mentioned.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical testing was not performed to validate the performance of the subject device." Therefore, no MRMC study for AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
The type of ground truth used: Not applicable, no AI/ML ground truth mentioned.
The sample size for the training set: Not applicable, no AI/ML training set mentioned.
How the ground truth for the training set was established: Not applicable, no AI/ML training set mentioned.

In summary, the provided document details the regulatory clearance process for a physical medical catheter through non-clinical bench and biocompatibility testing, not the evaluation of an AI-powered diagnostic or predictive device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 17, 2017

Vascular Solutions, Inc. Jake Schultz Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K170544

Trade/Device Name: Langston Dual Lumen Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: October 10, 2017 Received: October 11, 2017

Dear Jake Schultz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170544

Device Name Langston Dual Lumen Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: 11/15/2017

510(k) Number: K170544

Submitter's Name / Contact Person

Manufacturer	Contact
Vascular Solutions, Inc.	Jake Sch
6464 Sycamore Court North	Regulatory
Minneapolis, MN 55369 USA	Tel: 763
Establishment Registration # 2134812	Fax: 763

Person ultz ory Product Specialist -656-4300 3-656-4253

General Information

Trade Name	Langston dual lumen catheter
Common / Usual Name	Diagnostic intravascular catheter
Classification Product Code	DQO
Classification Name	21 CFR 870.1200 Diagnostic intravascular catheter
Predicate Devices	K061565, Langston dual lumen catheter, Vascular Solutions, IncK051395, Langston dual lumen catheter, Vascular Solutions, Inc

K170544 Device Models
Model	Description	Length	OuterLumenDiameter	Inner LumenDiameter	Max PressureRating
5515	145° Pigtail	125 cm	7 F	5 F	1200 psi
5540	145° Pigtail	110 cm	6 F	5 F	1000 psi
5550	Multipurpose A2	100 cm	6 F	4 F	1000 psi

Device Description

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Intended Use

The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients.

Technological Characteristics Comparison

The Langston dual lumen catheter has identical indications for use and principle of operation as the predicate devices and they are all diagnostic intravascular catheters. The subject and predicate devices are intended for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. The Langston dual lumen catheter is equivalent in design and technological characteristics to the predicate devices. The subject and predicate devices are dual lumen catheters sterilized via ethylene oxide and intended for single use. The proximal manifold of the Langston dual lumen catheter will be modified to remove the adhesive bonds and replace it with an over molded proximal manifold component. The manifold component introduces Nylon 12 Grilamid as a new material to the Langston dual lumen catheter. The extension line tubing material of the Langston dual lumen catheter will also be modified to increase stiffness and to remove the adhesive bond by including an additional strain relief.

Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence of Langston dual lumen catheter substantial equivalence. Clinical testing was not performed to validate the performance of the subject device. The Langston dual lumen catheter is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:

. Package Integrity
. Tortuosity in Simulated Anatomy
Pressure Monitoring
Flow Rate vs. Injection Pressure ●
. Tensile Force
Torque to Failure
Air Leakage During Aspiration ●
. Liquid Leakage Under Pressure
. Torque Strength
Dimensional Analysis ●
. Hub Luer Taper

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Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:

. Cytotoxicity
Sensitization .
Irritation ●
Acute Systemic Toxicity ●
. Pyrogenicity
Hemocompatibility

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Langston dual lumen catheter is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).